Neutralizing Antibody Combo Therapy Authorized for Certain COVID-19 Patients

Indianapolis-based Eli Lilly & Co. announced on February 9, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg combination.

This neutralizing antibody therapy is authorized to treat mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes.

Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, stated in a press release, "Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations. We are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit."

"Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 coronavirus variants as these new strains spread around the world."

The FDA says, 'Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’s attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.'